News and updates on potential cures for type-1 diabetes, that are in human (or clinical) trials.

Monday, July 21, 2008

LCT Reports Good Results from Phase-I Trials

LCT has just posted results from their Phase-I human trials. They are transplanting encapsulated pig islet cells. If successful, their cure will work on all type-1 diabetics. Even those who have been diabetic for years.

You can read the report here: http://www.lctglobal.com/news/LCTReportsClinicalBenefits.pdf my summary of it is below.

The Good NewsNo safety problems.80% of people's A1c went down, average went from 8.5 to 6.8 (the one who went up was just .3)All people's average insulin usage went down, on average by about 24% at end of study.One person used no injected insulin at all for a time.

The Bad NewsStudy is very small, only six people.Study is very short, a maximum of 12 months, most people were followed much less than that.Study was done in Russia.

When you look at these results (and the more detailed results in the PDF paper linked above) remember that this is a Phase-I trial. That means it is designed to test safety, not effectiveness, and that they usually give a very small dose during Phase-I trials. It is usual to only get partial effectiveness in these trials, because you are testing for safety. Phase-II is where you should see the higher effectiveness, because you can use higher doses.

So, with that in mind, I think it is clear that LCT's treatment can lower the use a of insulin quite a bit, and also lower A1c numbers, and that should lead to fewer complications. And this is all in a low dose Phase-I trial!

The big issue for me is: How long will it last? And the news here is not so good. The two patients who were followed for 12 and 11 months ended up with about half the insulin production that they started with. So after about 11 months they were only generating about 1/2 the insulin as when they were first implanted. The two patients who were followed for 5 and 4 months, one stayed the same, and the other dropped about 30%. I think it is going to be critical to find out what happens to the 6 patients over the next four or five years. (Plus any research LCT can do to see why less insulin is generated after 11 months.)

There is also an issue in making sure the patient generates all of their own insulin, so they don't need to inject any, but I'm assuming that just requires more islet cells, and I'm kind of assuming that is not a big deal. They can put in 4x as many islets, and get 4x as much insulin. I hope.

The obvious question is: What is the next step? Will LCT start a higher dose, Phase-II trail? Will they follow their Phase-I patients for longer? Will the do more patients as part of their Phase-I trial? Will they do all of these things? I don't know. But when I do know, you will know.

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This blog discusses cures and preventatives for type-1 diabetes that are either in human trials or just about to start. Treatments for diabetes are not generally discussed here, unless they can turn into a cure or a preventative. My definition of a cure is this:1. Blood sugar control without testing and with doctor's visits 4 times a year, or less. Any cure must result in an average lifespan close to normal.2. Does not require a lifetime of immunsuppressive drugs, so it is not trading one treatment for another. (but a couple of operations, or a short course of drugs is OK)Obviously, this is my personal definition of a cure; yours may differ.Because a cure for type-1 diabetes is likely to involve a combination of several different drugs or treatments, I try to follow research into anything which may be an important part of the cure.

My Non-Conflict of Interest Statement

For the first 10 years of running this blog, I did not work for a company doing medical research. In 2018, I started working for Bigfoot Biomedical, which is developing an "automated insulin dosing/delivery solution" (what many call an Artificial Pancreas).

I blog on research aimed at curing type-1 diabetes, and I view Bigfoot Biomedical's work as treating type-1 diabetes (not a cure at all). Therefore, I don't view this work as conflicting with my blogging. However, if you consider the kind of automated insulin dosing/delivery solution that Bigfoot is developing to be an actual cure for type-1, then this would conflict with my blogging. I think they are quite different.

I don't get paid in any way by any company working on a cure for type-1 diabetes; I never have. And that includes free samples, free travel, or free anything. I do sometimes participate in market research studies or focus groups, and they sometimes pay.

None of the hours that I have put into my blog, or the posts that I make to any web site, has ever been paid for. (Except for some very nice and heart felt thank-you emails, and those are worth more than money.)

My daughter has type-1 diabetes and participates in clinical trials. I sometimes report on trials that she participates in, but I do not reveal her participation because I consider her medical history to be private.

I sometimes "beta test" new software or devices involved in type-1 diabetes. When I'm blogging about something where I have been given special access, I say so.

In the past I have volunteered with JDRF and The NIIB Project. I currently am a fellow with JDCA. The JDRF and NIIB work was completely unpaid. JDCA has given me equipment that I use to help my blogging, and on one occasion paid for specific consulting work.